Diclofenac Sodium recalls

The FDA has published 6 recalls involving Diclofenac Sodium since 2013. The latest was reported on 3 Dec 2014. Actavis Laboratories, FL has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Dec 2014

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why diclofenac sodium is recalled

Other Reasons583%
Potency & Assay117%

Companies

Actavis Laboratories, FL350%
Watson Laboratories, Inc.-(Actavis) - Florida233%
Actavis117%

By year

2014583%
2013117%

All diclofenac sodium recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
3 Dec 2014Drug	CLASS II	Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol	Actavis Laboratories, FL	Other	Nationwide
8 Oct 2014Drug	CLASS II	Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol	Actavis Laboratories, FL	Other	Nationwide
8 Oct 2014Drug	CLASS II	Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol	Actavis Laboratories, FL	Other	Nationwide
19 Feb 2014Drug	CLASS II	Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol	Watson Laboratories, Inc.-(Actavis) - Florida	Potency & Assay	Nationwide
12 Feb 2014Drug	CLASS II	Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol	Actavis	Other	Nationwide
31 Jul 2013Drug	CLASS II	Diclofenac Sodium and Misoprostol Delayed-Release Tablets recalledDiclofenac Sodium And Misoprostol	Watson Laboratories, Inc.-(Actavis) - Florida	Other	Nationwide

Should you stop taking Diclofenac Sodium?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.